Formulated Phytosterols - A New Treatment For Benign Prostatic Hyperplasia

描述（申请人提供）：良性前列腺增生（Benign prostatic hyperplasia， BPH）是指前列腺肿大，在60岁男性中发病率为50%，随年龄增长发病率增加。这种不受控制的生长很可能是由双氢睾酮（DHT）引起的，并且由于尿流率恶化，夜尿症和急性尿潴留而导致生活质量下降。虽然目前使用药物治疗这种疾病，但许多男性更喜欢使用含有植物甾醇的产品，因为它们的副作用更小。不幸的是，许多这些产品中含有的甾醇的功效值得怀疑，很可能是因为它们不溶于水，生物利用度也不稳定。通过将植物甾醇与卵磷脂混合，生命线技术公司已经表明，这种组合使脂质甾醇在水中分散，从而增强了它们的生物活性。重要的是，这项专利技术被用于初步研究，表明适当配方的植物甾醇抑制类固醇5 α还原酶以降低DHT。此外，当在早餐饮料中给男性单剂量时，配制的甾醇也在给药后4小时降低了循环DHT。临床和生化实验的结果将扩展这些研究。首先，他们将提供植物甾醇与5 α还原酶之间抑制机制的定量描述。其次，在临床试验中，将确定甾醇给药后DHT抑制的完整时间过程，为剂量反应曲线提供基础。在这里开始的工作和在II期申请中进行的工作将导致一种新的非药物治疗BPH的方法。由于公认的植物固醇的安全性，拟议的产品将具有成本效益，没有副作用，并且可以在柜台购买。良性前列腺增生是一种慢性疾病，通过引起夜尿和尿流率恶化而降低老年男性的生活质量。本建议探索一种植物甾醇的配方方法，降低血液中二氢睾酮的水平，二氢睾酮是该疾病的推定病原体。由于公认的植物固醇的安全性，拟议的产品将具有成本效益，没有副作用，并且可以在柜台购买。

DESCRIPTION (provided by applicant): Benign prostatic hyperplasia (BPH) refers to the enlargement of the prostate gland, which occurs in 50% of 60-year old men with increasing incidence with age. This unchecked growth is most likely caused by dihydrotestosterone (DHT), and it produces a decreasing quality of life because of deterioration of urinary flow rate, nocturia and acute urinary retention. While drugs are currently used to treat this condition, many men would prefer to use plant sterol-containing products because they have fewer side effects. Unfortunately, the sterols contained in many of these products are of questionable efficacy, most likely because they are insoluble in water and have variable bioavailability. By mixing plant sterols with lecithin, Lifeline Technologies, Inc. has shown that this combination renders lipid sterols dispersible in water, which enhances their biological activity. Importantly, this patented technology was used in preliminary studies to show that properly formulated plant sterols inhibit steroid 5 alpha reductase to lower DHT. Moreover, when delivered to men as a single dose in a breakfast drink, formulated sterols also lowered circulating DHT 4 hours after administration. Results from the clinical and biochemical experiments outlined herein will extend these studies. First, they will provide a quantitative description of the mechanism of inhibition between plant sterols and 5 alpha reductase. Second in a clinical trial, a complete time course of DHT suppression will be determined after sterol administration, providing the basis for a dose response curve. The work inititated here and pursued in a Phase II application will lead to a new, non-pharmaceutical approach for the treatment of BPH. Because of the acknowledged safety of plant sterols, the proposed product will be cost effective, free of side effects and available over the counter. Benign prostatic hyperplasia is a chronic condition that lowers the quality of life in older men by causing nocturia and deterioration of urinary flow rate. This proposal explores a formulation method for plant sterols that lowers blood levels of dihyrotestosterone, the presumed causative agent of the disease. Because of the acknowledged safety of plant sterols, the proposed product will be cost effective, free of side effects and available over the counter.